2018
Epirubicin and Ifosfamide with Preoperative Radiation for High-Risk Soft Tissue Sarcomas
Lu E, Perlewitz KS, Hayden JB, Hung AY, Doung YC, Davis LE, Mansoor A, Vetto JT, Billingsley KG, Kaempf A, Park B, Ryan CW. Epirubicin and Ifosfamide with Preoperative Radiation for High-Risk Soft Tissue Sarcomas. Annals Of Surgical Oncology 2018, 25: 920-927. PMID: 29388122, DOI: 10.1245/s10434-018-6346-4.Peer-Reviewed Original ResearchConceptsSoft tissue sarcomasHigh-risk soft tissue sarcomasPhase II studyII studyPreoperative radiationTissue sarcomasHigh-grade soft tissue sarcomasHigh-risk STS patientsDistant disease-free survivalM2/dayExtensive institutional experienceLocal-regional failureDisease-free survivalRetrospective chart reviewDose-intense chemotherapyFavorable clinical outcomePercent of tumorsGy of radiationPostoperative cyclesTrimodality therapyPreoperative therapyWound complicationsChart reviewOverall survivalPathologic response
2011
Escalation Trial of Clofarabine Followed by Escalating Dose of Fractionated Cyclophosphamide in Adults with Relapsed or Refractory Acute Leukemias,
Zeidan A, Carraway H, Yun H, Greer J, Karp J. Escalation Trial of Clofarabine Followed by Escalating Dose of Fractionated Cyclophosphamide in Adults with Relapsed or Refractory Acute Leukemias,. Blood 2011, 118: 3615. DOI: 10.1182/blood.v118.21.3615.3615.Peer-Reviewed Original ResearchRefractory acute leukemiaAbsolute lymphocyte countAbsolute neutrophilic countDose level 1Dose-limiting toxicityOverall response rateAdverse cytogeneticsWhite blood cellsM2/dayClinical responseAcute leukemiaDay 1One-year disease-free survivalPhase I dose-escalation trialMedian absolute lymphocyte countElevated liver function testsAllogeneic stem cell transplantI dose-escalation trialTotal white blood cellsSecond-generation purine nucleoside analogDose level 3Dose level 4Dose of CYGrade 3 pneumoniaHand-foot syndromeA phase II study of the Ras-MAPK signaling pathway inhibitor TLN-4601 in patients with glioblastoma at first progression
Mason WP, Belanger K, Nicholas G, Vallières I, Mathieu D, Kavan P, Desjardins A, Omuro A, Reymond D. A phase II study of the Ras-MAPK signaling pathway inhibitor TLN-4601 in patients with glioblastoma at first progression. Journal Of Neuro-Oncology 2011, 107: 343-349. PMID: 22048878, DOI: 10.1007/s11060-011-0747-6.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic AgentsBrain NeoplasmsChromatography, LiquidDibenzazepinesErbB ReceptorsFemaleFollow-Up StudiesGene Expression Regulation, NeoplasticGlioblastomaHumansInfusions, IntraventricularKaplan-Meier EstimateMagnetic Resonance ImagingMaleMiddle AgedPTEN PhosphohydrolaseTandem Mass SpectrometryConceptsPharmacokinetic evaluationProgressive glioblastomaFirst progressionM2/dayPhase II studyMR scansPhase II trialContinuous intravenous administrationBlood-brain barrierLack of efficacyPeripheral benzodiazepine receptorEvaluable patientsStable diseaseII trialRadiographic progressionAdverse eventsII studyRecurrent glioblastomaDisease progressionDrug levelsIntravenous administrationBiomarker assessmentPatientsAnimal modelsBenzodiazepine receptors
2009
Tolerability of and adherence to combination oral therapy with gefitinib and capecitabine in metastatic breast cancer
Mayer EL, Partridge AH, Harris LN, Gelman RS, Schumer ST, Burstein HJ, Winer EP. Tolerability of and adherence to combination oral therapy with gefitinib and capecitabine in metastatic breast cancer. Breast Cancer Research And Treatment 2009, 117: 615-623. PMID: 19294501, PMCID: PMC4578795, DOI: 10.1007/s10549-009-0366-5.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerStable diseaseValidation cohortBreast cancerSequential cohortsPhase ICombination oral therapyOral antineoplastic therapyDays on/7Primary endpointSecondary endpointsOral therapyPartial responseAntineoplastic therapySerious toxicityDose reductionDrug dosesM2/dayCohortSignificant toxicityPatientsTherapyMTDCycle 1Capecitabine
2006
Triapine and cytarabine is an active combination in patients with acute leukemia or myelodysplastic syndrome
Yee KW, Cortes J, Ferrajoli A, Garcia-Manero G, Verstovsek S, Wierda W, Thomas D, Faderl S, King I, O’Brien S, Jeha S, Andreeff M, Cahill A, Sznol M, Giles FJ. Triapine and cytarabine is an active combination in patients with acute leukemia or myelodysplastic syndrome. Leukemia Research 2006, 30: 813-822. PMID: 16478631, DOI: 10.1016/j.leukres.2005.12.013.Peer-Reviewed Original ResearchMeSH KeywordsAcute DiseaseAdolescentAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsCytarabineDose-Response Relationship, DrugDrug Administration ScheduleDrug CombinationsFemaleHumansInjections, IntravenousLeukemia, MyeloidMaleMaximum Tolerated DoseMiddle AgedMyelodysplastic SyndromesPyridinesRecurrenceRisk FactorsThiosemicarbazonesTreatment OutcomeConceptsAra-C dose levelsDose levelsM2/dayAcute leukemiaSignificant anti-leukemia activityConsecutive daysPhase II regimenRefractory acute leukemiaHigh-risk MDSAnti-leukemia activityEvaluable patientsMyelodysplastic syndromeActive combinationPatientsPhase IIron chelatorsLeukemiaAraPotent inhibitorDaysTriapineRegimenCytarabineInfusionSyndrome
1995
Phase I trial of Adozelesin using the treatment schedule of daily × 5 every 3 weeks
Foster B, LoRusso P, Poplin E, Zalupski M, Valdivieso M, Wozniak A, Flaherty L, Kasunic D, Earhart R, Baker L. Phase I trial of Adozelesin using the treatment schedule of daily × 5 every 3 weeks. Investigational New Drugs 1995, 13: 321-326. PMID: 8824350, DOI: 10.1007/bf00873138.Peer-Reviewed Original ResearchConceptsMinute IV infusionTreatment scheduleM2/dayIV infusionPhase II starting doseRefractory soft tissue sarcomasConsecutive daysPhase IUnique alkylating agentRefractory solid tumorsPhase I trialSoft tissue sarcomasAdditional phase IPreclinical toxicology studiesBroad antitumor activityPotent synthetic analogsAnaphylactoid syndromeStarting doseI trialPartial responseAntitumor responseCumulative myelosuppressionTissue sarcomasTherapeutic dosesCytotoxic treatment
1992
Modulation of O6-alkylguanine-DNA alkyltransferase-mediated carmustine resistance using streptozotocin: a phase I trial.
Panella TJ, Smith DC, Schold SC, Rogers MP, Winer EP, Fine RL, Crawford J, Herndon JE, Trump DL. Modulation of O6-alkylguanine-DNA alkyltransferase-mediated carmustine resistance using streptozotocin: a phase I trial. Cancer Research 1992, 52: 2456-9. PMID: 1533174.Peer-Reviewed Original ResearchConceptsFmol/M2/dayDose-limiting toxicityPhase I trialDose of BCNUSerum alkaline phosphataseBCNU doseSTZ doseStarting dosePartial responseSerum creatinineThird doseDose escalationI trialMild elevationDay 3BCNU resistanceNitrosourea resistanceSTZBCNU cytotoxicityBCNUDoseAdditional studiesO6-alkylguanine-DNA alkyltransferaseAlkaline phosphatase
1987
Phase I trial of tiazofurin administered by i.v. bolus daily for 5 days, with pharmacokinetic evaluation.
Roberts JD, Stewart JA, McCormack JJ, Krakoff IR, Culham CA, Hartshorn JN, Newman RA, Haugh LD, Young JA. Phase I trial of tiazofurin administered by i.v. bolus daily for 5 days, with pharmacokinetic evaluation. Journal Of The National Cancer Institute 1987, 71: 141-9. PMID: 3802111.Peer-Reviewed Original ResearchConceptsTreatment interruptionTransient toxic effectsM2/dayTreatment coursePhase I clinical trialToxic effectsAntitumor activityPhase II trialPhase I trialBolus IV infusionFrequent treatment interruptionsSerum biochemical abnormalitiesSystemic toxic effectsCoadministration of allopurinolMurine tumor modelsUric acid productionLow dose levelsSignificant antitumor activityBolus dailyInjury manifestTransient pericarditisII trialSerum hemoglobinI trialIV infusion
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